UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031910 |
|---|---|
| Receipt number | R000036439 |
| Scientific Title | A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/09/30 10:02:55 |
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Basic information
Public title
A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Acronym
A randomized study of furosemide or mannitol in short hydration chemotherapy
Scientific Title
A randomized phase II study of furosemide or mannitol in cisplatin-based chemotherapy using short hydration
Scientific Title:Acronym
A randomized study of furosemide or mannitol in short hydration chemotherapy
Region
| Japan |
Condition
Condition
Chemotherapy naive thoracic malignancy
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of furosemide compared with mannitol in cisplatin-based chemotherapy(>=60mg/m2) using short hydration in chemotherapy naive patients with thoracic malignancy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The proportion of patients experienced >=Grade1 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the upper limit of the normal range (ULN) for serum creatinine at each institute)
Key secondary outcomes
1)The proportion of patients experienced >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute)
2) The proportion of patients experienced >=Grade1 and >=Grade2 renal dysfunction during the first cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the pretreatment baseline creatinine score in each patient)
3) The proportion of patients experienced >=Grade1 and >=Grade2 renal dysfunction after the completion of forth cycle (defined as elevation in creatinine, CTCAE Ver. 4.0, based on the ULN for serum creatinine at each institute and on the pretreatment baseline creatinine score in each patient)
4)The proportion of patients with phlebitis and severity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
20% mannitol 300ml, in 30min
Interventions/Control_2
furosemide 20mg, intravenous infusion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Thoracic malignancy
2)ECOG PS 0-1
3)Creatinine clearance rate of >=60mL/min
4)Previously untreated with cisplatin-based chemotherapy
Key exclusion criteria
With Superior Vena Cava syndrome
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama-city
TEL
0734410619
erikom@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Murakami |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama-city
TEL
0734410619
Homepage URL
erikom@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University Institutional Review Board
Address
811-1, Kimiidera, Wakayama-city
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/9/12/e029057
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
115
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2022 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036439
